Implantable penile prosthetic cylinder with inclusive fluid reservoir

ABSTRACT

A surgically implantable prosthesis for the treatment of penile erectile impotence in male patients. The device comprises at least one elongated cylinder implanted within one of the corpora cavernosa of the penis. The flexible, distal end of the cylinder is adapted to rigidize upon being filled with pressurizing fluid. The rear tip or proximal end of the cylinder is formed to provide a chamber which serves as a fluid reservoir. Valve means contained within the cylinder controls fluid flow between the rear tip reservoir and the flexible, distal end of the cylinder. The prosthesis further includes a manually operable pump means utilized to transfer pressurized fluid from the rear tip reservoir to the distal end of the cylinder in order to achieve an erection. The walls of the rear tip reservoir itself may serve as the pump means; or a separate pump may be implanted within the scrotum.

This application is a continuation of application Ser. No. 494,360,filed May 14, 1983, now abandoned; which is a continuation of Ser. No.264,202 filed May 15, 1981, now U.S. Pat. No. 4,383,525, which is acontinuation of Ser. No. 06/108,124 filed Dec. 28, 1979, now U.S. Pat.No. 4,267,829.

BACKGROUND OF THE INVENTION

This invention relates generally to the field of implantable medicalprosthetic devices for treating male erectile impotence, and moreparticularly to penile prosthetic implants operated by fluid pressuresupplied from an implanted pump device.

Implantable penile prostheses for the management of erectile impotenceutilizing inflatable cylinders which are implanted within the penis aredescribed and disclosed by Scott et al in Urology, Vol. II, No. 1, July1973, pp. 80-82; and by Kothari et al in the Journal of Biomechanics,Vol. V, 1972, pp. 567-570. The prosthetic devices disclosed in thosearticles comprise a reservoir to hold a radiopaque fluid used toactivate the device through inflatable cylinders adapted to be placedinside of the corpora cavernosa of the penis, and two pumping mechanismsfor inflating and deflating the cylinders. The inflatable cylinders aredisclosed as comprising collapsible tubes constructed of dacronreinforced silicone rubber and having a shape simulating the corporacavernosa. Valves are employed in the disclosed fluidic system in such away as to permit selective actuation of the pumping mechanisms toinflate and deflate the cylinders. In this manner, the patient is ableto selectively produce an erection and to return the penis to a flaccidstate by manual manipulation of the pumping mechanisms.

A method and device for achieving a penile erection is described byStrauch et al in U.S. Pat. No. 3,853,122. That patent discloses anelongated, flexible, and stretchable hollow tube implanted in the penis.A flexible, fluid container is provided for implantation in the scrotumor in the lower abdomen of the patient. Pressing on the implantedcontainer serves to displace the fluid into the tube to render the tuberelatively rigid, thus providing the desired erection.

Another penile prosthesis for the management of erectile impotence isdescribed by Uson in U.S. Pat. No. 4,009,711. Uson shows a body memberhaving a nondistensible portion and a distensible body portion, with thelatter being connected by suitable conduit means to a fluid supplysource implanted within the patient. The nondistensible portion ispreferably made of plastic material, such as Silastic, which isrelatively rigid and is adapted to be implanted into the root end of thecorpus cavernosum of the penis to anchor the prosthetic device in place.The distensible body portion is connected by fluid conduit means to apump bulb implanted within the scrotum. The Uson prosthesis is thusrigid at the root of the penis, and inflatable at the pendulous portionof the penis.

The penile erection system disclosed by Buuck in U.S. Pat. No. 3,954,102is an improved variation of that disclosed in the aforesaid Scott et aland Kothari et al articles. The Buuck patent discloses a pair ofinflatable and collapsible cylinders adapted to be implanted within thecorpora cavernosa of the penis and to simulate their function. Eachcylinder includes a cylindrical silicone rubber body or sleeve which isexpansible circumferentially and also longitudinally. A single pump bulbimplanted within the scrotum is utilized to selectively deliver fluid tothe inflatable cylinders through a valve system. A separate, fluidreservoir implanted within the abdomen of the male patient contains thefluid utilized to activate the inflatable cylinders. Pumping of thesqueeze bulb within the scrotum serves to transfer fluid from thereservoir to the cylinders. A manually actuable bypass valve containedwithin the pump bulb implanted within the scrotum is manipulated topermit pressurized fluid to flow from the cylinders back to the fluidreservoir in order to return the penis to a flaccid state.

Prior art inflatable penile prostheses as implanted and used in actualpractice have required relatively large fluid reservoirs as disclosed inthe Buuck patent to contain the amount of fluid necessary to inflateelongated, stretchable hollow tubes implanted in the penis. It isdisadvantageous to implant a large fluid reservoir in the scrotum. It isalso undesirable to implant separate structures, such as a fluidreservoir and connecting fluid conduits, at remote locations from thepenis or from a pump device implanted in the scrotum. Such fluidicsystems complicate the surgical implant procedure. One approach tosimplifying the implantable prosthesis, particularly with respect to thefluid pressurizing system, is disclosed in the aforesaid U.S.application Ser. No. 108,124, of which this application is acontinuation-in-part. In that copending application, there is discloseda pressurizable implant cylinder which is comprised of a substantiallyrigid front or distal portion, a rigid rear portion for mounting insidethe root end of the penis, and a tubular section attached to and mountedbetween the front and rear portions so as to define a chamber which isconnected to pump means. The tubular section is collapsible but resistsstretching so that the volume of the chamber undergoes only a smallchange as the penis is caused to go between a nonerect, bent conditionand an erect condition. Therefore, only a small volume of fluid isrequired to actuate the cylinder to an erect, rigid condition. The pumpmeans as disclosed in the aforesaid application may take the form of aseparate pump bulb implanted within the scrotum or a fluid chamberformed within the distal end of the implantable cylinder to provide afully self-contained implantable prosthesis.

The implantable penile prosthesis of this invention reflects a furtherimprovement and variation of a fluid pressurized prosthetic device witha simplified fluidic system which does not require a separate fluidreservoir implanted in the abdomen or other remote location.

BRIEF SUMMARY OF THE INVENTION

This invention is directed to an implantable penile prosthesis of thefluid operated type. A flexible, fluid pressurizable, cylinder adaptedto be implanted within the corpus cavernosum along the distal end of thepenis is combined with a fluid reservoir, pump means and control valvein a compact fluidics arrangement which greatly simplifies the implantsurgery required and reduces associated risk and patient discomfort.

A further object is to provide such a simplified penile prosthesis fortreatment of male impotence which permits the patient to readilymanipulate the pump and control valve to selectively produce an erectionor maintain the penis in a nonerect, flaccid state.

This invention also has as an objective the provision of an implantablepenile prosthesis which may be implanted, in part, in the scrotum butwhich does not occupy so much of the intrascrotal space as to interferewith the functioning of bodily organs contained therein or cause patientdiscomfort.

It is a further object to provide an implantable penile prosthesis ofthe aforesaid type which does not require the surgical implantation ofcomponents of the fluidics system at locations remote from the penis.

These basic objectives are realized by an implantable penile prosthesiscomprised of an elongated cylinder adapted to be preferably implantedwithin the corpus cavernosum of the penis, with the cylinder including afluid pressurizable distal end section and a self-contained fluidreservoir chamber formed within one end thereof. A valve mechanism forcontrolling the flow of fluid back and forth between the reservoirchamber and the distal end of the cylinder is also contained within thecylinder. The prosthesis further comprises pump means manually operableto transfer fluid under pressure from the reservoir chamber to thedistal end of the cylinder implanted within the distal or pendulous endof the penis for producing an erection.

Preferably, the proximal, rear or root end section of the cylinder isformed to provide the fluid reservoir chamber. In one preferredembodiment, the reservoir chamber within the implant cylinder alsoserves as the pump means. The walls of the rear end section of thecylinder forming the fluid reservoir are resiliently compressible; and,upon implantation, are accessible for direct manual pumping actionthrough the patient's perineal tissue. The aforesaid valve mechanism ispositioned within the implant cylinder so that upon implantation it willbe located within the penis where it will be accessible for manualactuation. Unseating the control valve through manual pressure permitsthe return flow of fluid to the fluid reservoir chamber from the distalsection of the implant cylinder for returning the penis to a flaccidstate.

In an alternative version of the prosthesis, the pump means comprises anelastomeric bulb adapted to be implanted within the scrotum. The pumpbulb is in fluid flow communication with the aforesaid reservoir chamberand distal end section of the implant cylinder through the valvemechanism contained within the cylinder. In this embodiment, the valvemechanism comprises check valves which function to permit fluid flowfrom the reservoir chamber to the distal end section of the cylinder asthe pump is actuated through the scrotal skin. Connector means betweenthe pump bulb and the valve mechanism allows the check valves to beunseated for returning fluid to the reservoir chamber from the distalend section of the cylinder, by manual manipulation of the pump bulbthrough the scrotal skin.

These and other objects and advantages of the invention will be readilyunderstood as the following description is read in conjunction with theaccompanying drawings wherein like reference numerals have been used todesignate like elements throughout the several views.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a top, plan view of one preferred embodiment of the penileprosthesis of this invention;

FIG. 2 is a fragmentary, section view showing the valve chamber andinterconnecting portions of the penile prosthesis cylinder, taken alonglines 2--2 of FIG. 1;

FIG. 3 is a section view of the valve mechanism of FIG. 1 taken alonglines 3--3 of FIG. 2;

FIG. 4 is a section view of the valve mechanism taken at the samelocation on FIG. 2 as is the view for FIG. 3, but showing the valve seatdisplaced to open the valve;

FIG. 5 is a side elevation view showing the penile prosthesis of FIG. 1implanted in a male with the prosthesis in a non-erect condition andwherein portions of the male anatomy including the penis and scrotum areshown in phantom;

FIG. 6 is a side elevation view showing an alternative embodiment of thepenile prosthesis as implanted in a male patient, with the prosthesis inan erect condition;

FIG. 7 is a section view showing the valve mechanism of the embodimentof the penile prosthesis depicted in FIG. 6, taken along lines 7--7 ofFIG. 6;

FIG. 8 is a section view showing the same valve mechanism as depicted inFIG. 7, but with the valves depicted in their pumping stroke positionswith fluid flowing from the pump to the distal end of the implantcylinder; and

FIG. 9 also shows the same cross section view of the valve assembly asdepicted in FIGS. 7 and 8, but with the valve assembly actuated to theposition which it will assume to permit reverse flow of fluid from thedistal cylinder to the fluid reservoir.

DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring now to the drawings, there is shown in FIGS. 1 through 5 onepreferred embodiment of the implantable penile prosthesis. Theprosthesis is comprises of an elongated cylinder generally indicated byreference numeral 1. Cylinder 1 is adapted to be implanted within thepatient's penis, and preferably within one of the corpus cavernosum ofthe penis. Cylinder 1 is comprised of a distal end section 2 and aproximal or root end section 4 separated by a valve section generallyindicated by reference numeral 6. Distal end section 2 is flexible andis adapted for implantation within the pendulous segment of the penis.To that end, distal section 2 is tapered along its length from a pointadjacent its end near valve section 6 towards its distal tip. This shapeconforms generally to the tapered shape of the corpora cavernosa of thepenis. More sharply tapered tip 8 is adapted to be positioned under theglans 10 of the penis as shown in FIG. 5. Thus, though the tubularprosthetic insert 1 is generally referred to as a cylinder, it is to beunderstood that the distal end section 2 of the cylinder is preferablytapered as described herein.

Distal end section 2 is formed from a medical grade, biocompatiblematerial which will permit it to flex and bend, whereby the penis mayassume a bent, nonerect condition as shown in FIG. 5; however, theconstruction of distal section 2 is such that it will be impervious tofluid, and will rigidize upon being filled with a pressurizing fluid soas to permit the penis to assume an erected state.

As may be noted most clearly by reference to FIGS. 1 and 2, distalsection 2 and proximal section 4 of the implant device 1 are preferablyformed from the same material joined together within valve section 6 ata sealed joint as by gluing to form a continuous tubular implantdevice 1. Proximal, root section 4 of the implant device is formed toprovide a fluid reservoir chamber indicated by reference numeral 12 inFIG. 2. Thus, in this manner, the reservoir chamber for pressurizingfluid is self-contained within the body of generally cylindricalprosthetic implant device 1. When implanted within a male patient asshown in FIG. 5, proximal reservoir chamber section 4 of implant 1 willbe positioned in the root segment of a corpus cavernosum. This locationensures the accessibility of reservoir chamber proximal section 4 formanual manipulation when it also serves as a pump as hereinafter setforth.

Also contained within the implant cylinder 1 is a valve sectiongenerally indicated by reference numeral 6. This valve section as shownin FIGS. 2-4 includes a valve block 14 which may be made of hard rubber,such as medical grade silicone. In the embodiments shown herein, valveblock 14 is positioned within cylinder 1 between fluid reservoir chamber12 and distal end section 2 of implant device 1. It is formed to includea valve seat 16 with which a valve poppet or element 18 cooperates toprovide a fluid flow control function between reservoir chamber 12 anddistal end section 2. Valve poppet 18 is connected by a stem 20 to avalve head 22. A coil spring 24 is positioned as shown between annularshoulder 26 of valve block 14 and valve head 22 so as to normally urgevalve poppet 18 to the left as viewed in FIG. 2 in a closing positionagainst seat 16. Valve block 14 is hollow internally so as to provide achamber accomodating the aforesaid valve components.

The valve section 6 and the joint between cylinder sections 2 and 4 ofthe implant cylinder 1 are preferably reinforced and sealed by a band orring 28 made of the same silicone or polyurethane material of whichcylinder 1 is constructed. A charging tube 30 extends throughreinforcing band 28 and the wall 1a of cylinder 1 surrounding valveblock 14 and connects with an internal flow passage 32. Tube 30 servesfor initially charging fluid into cylinder 1 for containment withinreservoir chamber 12 and distal end section 2. The fluid with whichcylinder 1 is charged will be a biocompatible, preferably radiopaqueliquid, such as a saline solution which is noncompressible.

A one piece stiffener generally indicated by reference numeral 34 ispositioned within the walls of cylinder 1 defining proximal, rootsection 4 forming reservoir chamber 12. Stiffener 34 is preferably madefrom stainless steel and includes a rod 36 extending between a roundedend 35 and a continuous skirt head comprised of a conical segment 40 anda cylindrical skirt 38. Skirt 38 is imbedded within the rubber formingvalve block 14 and is apertured as shown for secure retention within thesilicone rubber from which valve block 14 is molded. The opposite,rounded end 35 of stiffener 34 bears against the extreme, proximal endof the root section 4 of implant cylinder 1. Apertures 42 formed in theconical segment 40 of stiffener 34 permit unimpeded fluid flow fromreservoir chamber 12 into the valve chamber formed within valve block14, and thence into distal end section 2 through valve seat or port 16.Stiffener 34 supports the flexible walls forming the proximal, reservoirportion 4 of cylinder 1 at all times. The strength and rigidity whichstiffener 34 lends to proximal section 4 of the implant deviceparticularly aids in the insertion of proximal section 4 within the rootend of the corpora cavernosa of a male patient at the location shown inFIG. 5.

In the embodiment of the penile prosthesis shown in FIGS. 1-5, theproximal root section 4 of the implant cylinder 1 which serves asreservoir chamber 12 also functions as the pump means. The walls ofcylinder 1 defining proximal section 4 are resiliently compressibleinwardly. Thus, the application of external pressure to proximal section4 will cause fluid to be expelled therefrom under pressure into distalsection 2 through valve 16-18. As noted above, cylinder 1 is adapted tobe surgically implanted within the corpus cavernosum of the penis.Although one implant cylinder 1 could be satisfactorily utilized, it isanticipated that two separate prosthetic implant cylinders 1 will beutilized, with one of such cylinders being implanted within each of thecorpus cavernosum of the penis in the manner shown in FIG. 5. Such adouble cylinder prosthetic system provides a measure of redundency incase one cylinder should fail. The surgical procedure for implanting twoof the cylinders 1 within the corpora cavernosa is substantially thesame as that described in U.S. Pat. No. 3,954,102 with respect to theinflatable, prosthetic cylinders. Cylinders 1 are inserted into thecorpora cavernosa through an incision made at the base of the penis. Thecorpora cavernosa regions of the penis are first dilated, as by theinsertion of a metal rod through the incision to displace the erectiletissue and create a space for the subsequent insertion of the prostheticcylinders 1. After insertion, distal end section 2 will extend withinthe pendulous portion of the penis, and proximal section 4 of thecylinder will extend into the root end of the corpora cavernosa as shownin FIG. 5. Proximal section 4 comprising the combined fluid reservoirand pump will be located within the root end of the corpora cavernosa atthe location where it may be subjected to compression and pumping actionby the application of manual pressure to the patient's perineal tissue.The arrow in FIG. 5 indicates the location and direction of theapplication of manual pressure to the perineum for compressing the wallsof pump-reservoir section 4 of cylinder 1. Such a pressing action willforce fluid under pressure from proximal, reservoir section 4 againstvalve poppet 18, thereby overcoming the pressure of spring 24 anddisplacing valve poppet 18 to an open position with respect to seat 16.Pressurized fluid is thus caused to flow from reservoir 12 into distalend section 2. The resultant rigidizing of distal section 2 under fluidpressure produces an erection. When it is desired to return the penis toa flaccid state, it is only necessary for the patient to apply pressureto valve section 6 of the implant device. This may be done by utilizingthe thumb and forefinger to apply squeezing pressure to the tissueadjacent the base of the penis. The resultant squeezing action at thevalve location defined by reinforcing band 28 will cause valve seat 16to be compressed in one direction and elongated in the oppositedirection as shown in FIG. 4. FIG. 3 illustrates the condition of thevalve assembly in its normal, rest condition free from the applicationof any such squeezing pressure. The vertical deformation of valve seat16 as illustrated in FIG. 4 results in the forming of openings 44adjacent the top and bottom of valve poppet 18. Fluid flows from distalend section 2 of cylinder 1 through openings 44 back into reservoirchamber 12, thereby depressurizing distal end section 2 and causing itto collapse to the condition shown in FIG. 5. This permits the penis toreturn to the nonerect state of FIG. 5. The use of squeezing pressure tomanipulate valves 16-18 to an open condition is substantially the sameas that described for the bypass, squeeze valve in FIGS. 10-12 of U.S.Pat. No. 3,954,102. It is to be noted that valve section 6 of the penileprosthesis is positioned along cylinder 1 at such a location that itwill be located substantially as shown in FIG. 5 adjacent the base endof the penis and just inwardly from the body plane of the patient whereit will be accessible to squeezing pressure applied to the skin adjacentthe base of the penis.

An alternative embodiment of the implantable penile prosthesis is shownin FIGS. 6-9. The implantable prosthetic cylinder 1 is substantiallyidentical to that illustrated in FIGS. 1 and 2. Thus, the implantableprosthetic cylinder comprises a distal end section 2 which ispressurizable to assume a rigid condition, a proximal, root section 4which serves as a fluid reservoir chamber 12, and a valve section 6which may be conveniently located between the distal and root cylindersections 2 and 4. Rather than utilizing the proximal section 4 ofcylinder 1 as the pumping means, a separate elastomeric bulb 46 isemployed as a pump device. Bulb 46 is sized to fit conveniently withinthe scrotal sac of the patient as illustrated in FIG. 6, and isconnected to the valve section 6 by means of flexible and stretchableelastomeric tubing 48. Tubing 48 may be made out of the same siliconerubber utilized for pump bulb 46. Stretchable tube 48 serves as a fluidconduit connecting pump bulb 46 to a valve chamber 50 formed within avalve block 52 contained within implant cylinder 1. Valve block 52 ismolded from solid rubber, preferably medical grade silicone in the samemanner as is valve block 14 of the embodiment shown in FIGS. 1 and 2.Valve block 52 may also be located within cylinder 1 between reservoirchamber 12 of proximal section 4 and distal section 2 of the implantcylinder for convenient connection with pump bulb 46 through tube 48. Aswith the embodiment of FIGS. 1 and 2, valve section 6 may be reinforcedby a band or ring 28 made of the same silicone or polyurethane materialof which cylinder 1 is constructed. A stiffener 34 of the same shape andconstruction as illustrated and described above with respect to FIGS. 1and 2 may also preferably be utilized to lend rigidity and strength toproximal, flexible wall reservoir section 4 of implant cylinder 1.Stiffener 34 is affixed to rubber valve block 52 and positioned withinproximal section 4 of the implant cylinder in the same manner asdescribed above with respect to FIGS. 1 and 2.

Since the reservoir chamber 12 for the pressurizing fluid is formedwithin proximal section 4 of the implant cylinder, pump bulb 46 needonly function as a fluid transfer pump. Accordingly, pump bulb 46 is ofa relatively small size, and may be implanted within the scrotal sac asshown in FIG. 6 without unduly interfering with bodily organs containedtherein or causing discomfort to the patient. Pump bulb 46 is in fluidflow communication with reservoir chamber 12 and distal section 2 of theimplant cylinder through conduit tube 48 and valve chamber 50. The flowof fluid between these components of the system is controlled by a valvemechanism positioned within valve block 52. A first check valvecomprised of a valve seat 54 formed within valve block 50 and a valvepoppet 56 controls flow between fluid reservoir chamber 12 and pump bulb46. A valve stem 58 is slidably positioned within U-shaped poppetelement 56 in slidable relation thereto. Stem 58 is normally urged tothe left as viewed in FIG. 7 against poppet 56 to hold it in a closedposition against valve seat 54 by a coil spring 60 bearing against stemcollar 62. The opposite end of spring 60 bears against an annularshoulder 64 formed on valve block 52. Pressure differentials createdacross valve seat 54 by the pumping action of bulb 46 permit valvepoppet 56 to be unseated only so as to permit fluid flow in a directionfrom reservoir chamber 12 through valve chamber 50 to pump bulb 46.

A second check valve comprised of a valve seat 66 and valve head 68controls the flow of fluid between valve chamber 50 and distal endsection 2 of the implant cylinder. Valve seat 66 preferably takes theform of a ring molded integrally with valve block 52 and protrudinglaterally from one side thereof as shown in FIG. 7. Valve head 68 isnormally held in seating engagement therewith by coil spring 60. Valvestem extension 70 on which valve head 68 is formed may be moldedintegrally with valve stem 58 or securely affixed thereto for shiftingmovement therewith in a longitudinal direction.

The valve assembly further includes means for manually manipulating thefirst and second check valves 54-56 and 66-68 to open positions topermit fluid flow from distal end section 2 back into fluid reservoirchamber 12. For this purpose, an elongated, flexible connector 72 isattached between valve stem 58 and stretchable tube 48. Flexibleconnection 72 may take the form of a dacron cord or a medical suture. Atits upper end it is affixed to a sleeve 74 received within a recess 76formed in the collar 62 of valve stem 58. The bottom end of connectorcord 72 may be looped through the side wall of stretchable tube 48 andsecured hereto by a knot as illustrated in FIGS. 7-9. A retention band78 is affixed around stretchable tube 48 over the location of attachmentof cord 72 thereto in order to secure and hold the bottom end of cord 72in place. Band 78 may also be a ring of silicone rubber.

The prosthetic device illustrated in FIGS. 6-9 is implanted insubstantially the same way as that described above with respect to theembodiment of FIGS. 1-5. Distal end section 2 of the implant cylinder 1will be contained within one of the corpus cavernosum of the penis, andproximal, fluid reservoir section 4 thereof will be located within theroot end of one of the corpus cavernosum. Pump bulb 46 is located withinthe scrotal sac as stated above. When the patient desires to achieve anerection, pumping action is applied to bulb 46 by applying squeezingpressure thereto through the scrotal sac. Repetitive, squeezingmanipulation of pump bulb 46 in that manner will have the effect oftransferring fluid from reservoir chamber 12 to distal end section 2 ofthe implant cylinder. As the walls of pump bulb 46 are releasedoutwardly on the suction stroke of each pumping manipulation, valvepoppet 56 will be drawn out of seating engagement with seat 54 and willshift to the right as viewed in FIG. 7 along valve stem 58. This permitsfluid to flow from reservoir chamber 12, through valve chamber 52 andinto pump bulb 46 through conduit 48. As the pump bulb is sequentiallysqueezed on the pumping stroke as illustrated in FIG. 8, the pressurizedfluid within valve chamber 50 will force poppet 56 back to the leftagainst seat 54. Simultaneously, the pressurized fluid acting on theunderside of valve head 68 will shift it to the right as viewed in FIG.8, overcoming spring pressure 60, to open valve seat 66. Fluid is thuspermitted to flow under pressure into distal end section 2 of theimplant cylinder. This causes flexible distal section 2 to elongate andrigidize as shown in FIG. 6 thereby producing an erection.

When it is desired to return the penis to a flaccid state, the patientmanually exerts a downward, pulling action on pump bulb 46 through thewalls of the scrotal sac. This has the effect of stretching tube 48downwardly along its length and simultaneously pulling connecting cord72 downwardly. Cord 72 will normally be slack when the valve mechanismis in the condition shown in FIG. 7. Downward pulling action on theconnecting cord 72 through the aforesaid pulling manipulation of pumpbulb 46 and stretchable tube 48 causes the valve assembly containedwithin valve block 52 to be canted or tipped to the open position shownin FIG. 9. When the valve stem 58-70 is displaced by pulling on core 72,valve poppet 56 and valve head 68 will be angularly displaced to thecanted positions shown in FIG. 9, thereby opening flow ports or valveseats 54 and 66. Thus, fluid is permitted to flow from distal endsection 2 back into reservoir chamber 12 and into pump bulb 46.

As stated above, distal end section 2 of the implant cylinder 1 is madeof flexible, medical grade material which will permit it to collapse andbend to the condition shown in FIG. 5. Distal end section 2 is alsoinflatable to the extent that it may be rigidized in a straightcondition for producing an erection as illustrated in FIG. 6. The term"inflatable" as used herein is intended to mean a penile prosthesis ofthe type having a distal end section 2 which is flexibly bendable topermit the penis to assume a flaccid state, but which rigidizes uponbeing pressurized to produce an erection. The implant cylinder asdisclosed herein may be made of silicone or polyurethane so that distalend section 2 is expandable in girth and length; or it may be made ofmaterials which permit distal end section 2 to distend only to a limitedextent. The latter type of cylinder has the advantage that it can berigidized with a lesser volume of fluid. Such a limited distensiblecylinder can be made of silicone or polyurethane reinforced by dacronfibers. The fiber reinforcing limits the ability of distal section 2 todistend. The fiber reinforced implant cylinder may be made in the samemanner as the limited distensible fluid chamber of the implant cylinderdescribed in the aforesaid copending U.S. application Ser. No. 108,124.

It will readily be appreciated that the implantable prosthetic cylinderas disclosed herein with its self-contained fluid reservoir chamber atone end thereof will greatly simplify surgical implant procedures. Noseparate, reservoir chamber containing fluid is required to be implantedwithin the patient at a location remote from the penis. The embodimentillustrated and described with respect to FIGS. 1-5 also eliminates theneed for a separate pump bulb by utilizing the proximal reservoirchamber section of the implant cylinder as the pumping device. Withrespect to the embodiment of FIGS. 6-9, the utilization of a fluidreservoir chamber formed within the implant cylinder, and thecontainment of the valve mechanism within the implant cylinder itself,permits the separate pump bulb implanted within the scrotal sac to be ofrelatively small size.

It is anticipated that various changes may be made in the construction,shape and operation of the penile prosthetic devices as disclosed hereinwithout departing from the spirit and scope of the invention as definedby the following claims.

What is claimed is:
 1. An implantable penile prosthesis comprising: atleast one elongated cylinder adapted to be implanted within a patient'spenis, said cylinder having a flexible distal end section forimplantation within the pendulous penis which is constructed to rigidizeupon being filled with pressurizing fluid, and a proximal, rear endsection adapted to be implanted within the root end of the penis; afluid reservoir chamber formed within said proximal, rear end section ofsaid cylinder; valve means contained within said cylinder forcontrolling the flow of fluid back and forth between said fluidreservoir chamber and said flexible distal end of said cylinder; andmanually operable pump means operatively connected with said valve meansand for transferring fluid under pressure from said fluid reservoirchamber to said flexible distal end of said cylinder for achieving anerection.
 2. The prosthesis of claim 1, wherein said pump is locatedexternal to said elongated cylinder of said penile prosthesis.
 3. Apenile prosthesis, comprising:a cylinder adapted to be implanted withina patient's penis, said cylinder having a fluid chamber adapted torigidize upon being filled with fluid, said fluid chamber adapted tolie, at least partially, in the pendulous penis when implanted in thepatient; a fluid reservoir within said cylinder, said fluid reservoir ina proximal end of said cylinder adapted to be implanted, at leastpartially, in the root end of the penis; a valve in said cylinder, saidvalve operatively coupled between said fluid reservoir and said fluidchamber to control the flow of fluid between said reservoir and chamber;and a pump operatively connected with said valve for moving fluid fromsaid fluid reservoir, through said valve, and into said fluid chamber.4. An implantable penile prosthesis, comprising: a cylinder adapted tobe implanted within a patient's penis and to extend from the proximalportion of the penis into the pendulous portion of the penis, saidcylinder comprising: a pressurizable fluid chamber in the portion ofsaid cylinder adapted to extend into the pendulous portion of the penis,said chamber adapted to become generally rigid when pressurized withfluid; a fluid reservoir, said fluid reservoir at least primarily in theportion of said cylinder adapted to lie within the proximal portion ofthe penis, said reservoir adapted to hold at least that volume of fluidnecessary to rigidize said pressurizable fluid chamber from anon-rigidized state; a valve operatively arranged in a fluid pathbetween said fluid reservoir and said fluid chamber; and a pumpoperatively connected with said valve for selectively transferring avolume of fluid from said reservoir to aid cylinder to pressurize saidchamber and to cause rigidization of said chamber.
 5. An implantablepenile prosthesis for implanting completely within a patient's peniscomprising at least one elongated member having a flexible distalforward section for implantation within the pendulous penis, saidforward section being constructed to rigidize upon being filled withpressurizing fluid; a proximal, rearward section adapted to be implantedwithin the root end of the penis, said rearward section containing afluid reservoir chamber, externally operable pump means in said memberfor transferring fluid under pressure to said flexible distal forwardsection of said member for achieving an erection; and valve meanspositioned within said member which open when said pump is operated sothat fluid is forced from said pump through said valve means into saidflexible distal forward section of said member.
 6. An implantable penileprosthesis of claim 5 in which the flexible distal forward section ofthe member includes a non-distensible pressure chamber.
 7. Animplantable penile prosthesis of claim 5 wherein said fluid reservoir iscompressible and when said fluid reservoir is compressed said fluidreservoir functions as said pump.
 8. An implantable penile prosthesiscomprising: at least one elongated cylinder adapted to be implantedwithin a patient's penis, said cylinder having a flexible distal endsection for implantation within the pendulous penis which is constructedto rigidize upon being filled with pressurizing fluid, and a proximal,rear end section adapted to be implanted within the root end of thepenis; a compressible fluid reservoir chamber formed within saidproximal, rear end section of said cylinder; valve means containedwithin said cylinder for controlling the flow of fluid back and forthbetween said fluid reservoir chamber and said flexible distal end ofsaid cylinder; and said fluid reservoir chamber when manually compressedfunctioning as a pump for transferring fluid under pressure from saidfluid reservoir chamber to said flexible distal end of said cylinder forachieving an erection.
 9. An implantable penile prosthesis, comprising:a cylinder adapted to be implanted within a patient's penis and toextend from the proximal portion of the penis into the pendulous portionof the penis, said cylinder comprising: a pressurizable fluid chamber inthe portion of said cylinder adapted to extend into the pendulousportion of the penis, said chamber adapted to become generally rigidwhen pressurized with fluid; a compressible fluid reservoir, said fluidreservoir at least primarily in the portion of said cylinder adapted tolie within the proximal portion of the penis, said reservoir adapted tohold at least that volume of fluid necessary to rigidize saidpressurizable fluid chamber from a non-rigidized state; a valveoperatively arranged in a fluid path between said fluid reservoir andsaid fluid chamber; and said fluid reservoir when manually compressedfunctioning as a pump for selectively transferring a volume of fluidfrom said reservoir to said cylinder to pressurize said chamber and tocause rigidization of said chamber.
 10. A penile prosthesis, comprising:a cylinder adapted to be implanted within a patient's penis, saidcylinder having a fluid chamber adapted to rigidize upon being filledwith fluid, said fluid chamber adapted to lie, at least partially, inthe pendulous penis when implanted in the patient; a compressible fluidreservoir within said cylinder, said fluid reservoir in a proximal endof said cylinder adapted to be implanted, at least partially, in theroot end of the penis; a valve in said cylinder, said valve operativelycoupled between said fluid reservoir and said fluid chamber to controlthe flow of fluid between said reservoir and chamber; and said fluidreservoir when manually compressed functioning as a pump for movingfluid from said fluid reservoir, through said valve, and into said fluidchamber.